Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

Program Format
Entry Terms
Fall: September 16, 2019, and October 28, 2019
Winter: January 6, 2020, and February 18, 2020
Credits Required for Graduation
45 Quarter Hours


As U.S. Food and Drug Administration laws and international policy perspectives change and evolve, the need for regulatory affairs professionals continues to grow. The Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices is designed to prepare regulatory affairs professionals with the knowledge surrounding the regulation of drug, biologic, and medical device commercialization in the global marketplace.

Courses cover compliance with applicable laws and regulations in the strategic analysis, communication, and commercialization of healthcare products. Program objectives focus on developing intellectual and practical frameworks to prepare you for work within regulatory affairs and quality assurance departments, medical product development, drug manufacturing, pharmaceutical sales, strategic marketing, and clinical investigations.

Offered fully online, the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices allows students to choose one of six unique concentrations offerings:

  • Operational Regulatory Affairs
  • Strategic Regulatory Affairs
  • Clinical Research Regulatory Affairs
  • International Regulatory Affairs
  • Regulatory Compliance
  • General Regulatory Affairs.

Program Objectives

  • Gain the essential knowledge and skills required to help companies navigate an increasingly complex regulatory environment
  • Acquire the foundation necessary to work within a variety of fields, including medical product development, pharmaceutical sales, strategic marketing, and clinical investigations
  • Examine every step of the drug development and regulation process
  • Sharpen your understanding of the laws that govern the development, manufacturing, and commercial distribution of drugs, biologics, and medical devices
  • Analyze how emerging developments and trends are reshaping medical device regulations

Certificate Information

If now is not the right time for you to enroll in a Northeastern University–Seattle master’s degree program, but you know that advanced study will enhance your skills and career potential, consider our graduate certificate programs.

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